A Clinical Trial of Scopolamine Versus Placebo for Individuals with Bipolar Disorder who are Experiencing a Depressive Episode (SCOPE-BD)

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10004937Term: Bipolar disorder NECSystem Organ Class: 100000004873; Bipolar Disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-003112-39-IE
• Lead Sponsor: ational University of ireland Galway

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

To be eligible each participant must meet all of the following eligibility criteria at Screening (Visit 1) and must continue to fulfil these criteria at Visit 2 to take part in the trial:

1.Diagnosis of Bipolar Disorder according to Diagnostic Statistics Manual (DSM)-V criteria
2.Experiencing an episode of depression of at least moderate severity at Visit 1 (Screening) and Visit 2 based on clinical interview by a trained clinician and a Hamilton Depression Rating Scale (HDRS) score = 14.
3.= 18 years old at Visit 2 (male or female)
4.In the opinion of the Principal Investigator or Sub Investigator’s, be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
5.Written informed consent prior to participating in the study
6.U&Es, LFTs and TFTs laboratory tests within acceptable ranges in the previous 4 months of the Screening Visit (Visit 1).

Placebo run-in inclusion criteria at Randomisation visit (Visit 3):
7. In addition to above participants must be experiencing an episode of depression of at least mild severity (having previously experienced an episode of moderate depression at Visit 2 with HDRS = 14), based on clinical interview by a trained clinician and a HDRS score of = 8.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Participants who meet any one or more of the following exclusion criteria at Screening (Visit 1) or Visit 2 will not be eligible to take part in the trial:

1.History of other Axis I diagnosis (including Recurrent Depressive Disorder or Psychotic Disorders such as schizo-affective disorder, conditions that can also present with depressive episodes)
2.History in the three months prior to Visit 2 of alcohol dependence syndrome or substance dependence syndrome.
3.Current use of oral steroid at Visit 1
4.A confirmed diagnosis of dementia
5.A diagnosis of intellectual disability (IQ < 70)
6.Participants with bipolar disorder that are euthymic in the investigator’s opinion, at screening or Visit 2.
7.Participants with bipolar disorder that are hypomanic or manic (Young Mania Rating Scale (YMRS) > 6) at screening or Visit 2.
8.Presence of an established neurological disorder or other serious demyelinating conditions as determined by the treating physician (e.g. space occupying lesion, multiple sclerosis)
9.Current involuntary detention under the Mental Health Act (MHA) 2001 in an acute psychiatric inpatient unit
10.Severity of Bipolar Disorder is such that participation in a clinical trial is not appropriate because of the risk of imminent self-harm (based on clinical note review and review at screening visit by experienced clinician)
11.A history of an allergic reaction or sensitivity to Scopolamine (Hyoscine Hydrobromide). Participants will be asked at the screening visit about any previous treatment with scopolamine (Hyoscine Hydrobromide) to ascertain any previous allergic reaction or sensitivity to this agent.
12.A clinical diagnosis of narrow angle glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, toxic megacolon and acute porphyria.
13.Individuals will be excluded from the study if currently prescribed anticholinergic medications including Physostigmine, Biperiden and Procyclidine. Individuals will additionally be excluded if currently prescribed Tricyclic Antidepressants which are associated with significant anticholinergic properties (e.g. Amitriptyline and Nortriptyline) that are currently causing the participant to experience anticholinergic side effects (e.g. blurred vision, constipation, urinary retention, cognitive difficulties). No individuals will have anticholinergic medications stopped to allow them enter the trial.
14.Bradycardia < 50 bpm, tachycardia > 100bpm or hypotension (systolic BP <90 and / or diastolic BP < 60) prior to IV administration of placebo or Scopolamine
15.A recent history in the last 6 months of symptomatic orthostatic hypotension or syncope.
16.Previous participation in this trial. Participation is defined as randomised. Participation in another trial within 3 months prior to Visit 1. Receipt of any investigational medicinal product (IMP) within 3 months prior to Visit 1.
17.Participants concurrently being administered Electroconvulsive Therapy (ECT).
18.Pregnancy, as determined by a positive urine dipstick at Visits 2, 3, 4, 5, positive blood serum result executed at Visit 2 and confirmed prior to infusion at Visit 3 or participants who are actively breastfeeding (female only).
19.Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include:
•Female sterilization (have had surgical

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified